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      Coach-Supported Versus Self-guided Digital Training Course for a Problem-solving Psychological Intervention for Nonspecialists: Protocol for a Pre-Post Nested Randomized Controlled Trial

      , BA, MA, MPhil, PhD 1 , , BSc, MSc, DPhil 2 , , AB, MS, Scd 2 , , BSc, PhD 3 , , BSc, MSc, PhD 4 , , BA, MA 1 , , BSc 1 , , BA, MA 1 , , BA, MSc 1 , , BA, MA, MPhil, PhD 5 , , MA, MSc, DClinPsy 3 , 6 , , MBBS, MSc, MRCPE, PhD 7 ,
      JMIR Research Protocols
      JMIR Publications
      adolescent mental health, capacity building, digital training, India, problem-solving intervention, randomized controlled trial

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          Psychosocial interventions delivered by nonspecialists can be effective at reducing common adolescent mental health problems in low-resource settings. However, there is a lack of evidence on resource-efficient methods for building capacity to deliver these interventions.


          The objective of this study is to evaluate the effects of a digital training (DT) course, delivered in a self-guided format or with coaching, on nonspecialists’ competency to deliver a problem-solving intervention intended for adolescents with common mental health problems in India.


          We will conduct a pre-post study with a nested parallel, 2-arm, individually randomized controlled trial. The study aims to recruit 262 participants, randomized 1:1 to receive either a self-guided DT course or a DT course with weekly individualized coaching provided remotely by telephone. In both arms, the DT will be accessed over 4 to 6 weeks. Participants will be nonspecialists (ie, without prior practice-based training in psychological therapies) recruited from among university students and affiliates of nongovernmental organizations in Delhi and Mumbai, India.


          Outcomes will be assessed at baseline and 6 weeks post randomization using a knowledge-based competency measure that incorporates a multiple-choice quiz format. The primary hypothesis is that self-guided DT will lead to increased competency scores among novices with no prior experience of delivering psychotherapies. The secondary hypothesis is that digital training with coaching will have an incremental effect on competency scores compared with DT alone. The first participant was enrolled on April 4, 2022.


          The study will address an evidence gap on the effectiveness of training methods for nonspecialist providers of adolescent mental health interventions in low-resource settings. The findings from this study will be used to support wider efforts to scale up evidence-based mental health interventions for young people.

          Trial Registration

          ClinicalTrials.gov NCT05290142; https://clinicaltrials.gov/ct2/show/NCT05290142

          International Registered Report Identifier (IRRID)


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          Most cited references31

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          The REDCap consortium: Building an international community of software platform partners

          The Research Electronic Data Capture (REDCap) data management platform was developed in 2004 to address an institutional need at Vanderbilt University, then shared with a limited number of adopting sites beginning in 2006. Given bi-directional benefit in early sharing experiments, we created a broader consortium sharing and support model for any academic, non-profit, or government partner wishing to adopt the software. Our sharing framework and consortium-based support model have evolved over time along with the size of the consortium (currently more than 3200 REDCap partners across 128 countries). While the "REDCap Consortium" model represents only one example of how to build and disseminate a software platform, lessons learned from our approach may assist other research institutions seeking to build and disseminate innovative technologies.
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            SPIRIT 2013 statement: defining standard protocol items for clinical trials.

            The protocol of a clinical trial serves as the foundation for study planning, conduct, reporting, and appraisal. However, trial protocols and existing protocol guidelines vary greatly in content and quality. This article describes the systematic development and scope of SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) 2013, a guideline for the minimum content of a clinical trial protocol.The 33-item SPIRIT checklist applies to protocols for all clinical trials and focuses on content rather than format. The checklist recommends a full description of what is planned; it does not prescribe how to design or conduct a trial. By providing guidance for key content, the SPIRIT recommendations aim to facilitate the drafting of high-quality protocols. Adherence to SPIRIT would also enhance the transparency and completeness of trial protocols for the benefit of investigators, trial participants, patients, sponsors, funders, research ethics committees or institutional review boards, peer reviewers, journals, trial registries, policymakers, regulators, and other key stakeholders.
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              SPIRIT 2013 explanation and elaboration: guidance for protocols of clinical trials

              High quality protocols facilitate proper conduct, reporting, and external review of clinical trials. However, the completeness of trial protocols is often inadequate. To help improve the content and quality of protocols, an international group of stakeholders developed the SPIRIT 2013 Statement (Standard Protocol Items: Recommendations for Interventional Trials). The SPIRIT Statement provides guidance in the form of a checklist of recommended items to include in a clinical trial protocol. This SPIRIT 2013 Explanation and Elaboration paper provides important information to promote full understanding of the checklist recommendations. For each checklist item, we provide a rationale and detailed description; a model example from an actual protocol; and relevant references supporting its importance. We strongly recommend that this explanatory paper be used in conjunction with the SPIRIT Statement. A website of resources is also available (www.spirit-statement.org). The SPIRIT 2013 Explanation and Elaboration paper, together with the Statement, should help with the drafting of trial protocols. Complete documentation of key trial elements can facilitate transparency and protocol review for the benefit of all stakeholders.

                Author and article information

                JMIR Res Protoc
                JMIR Res Protoc
                JMIR Research Protocols
                JMIR Publications (Toronto, Canada )
                13 June 2023
                : 12
                : e41981
                [1 ] Sangath New Delhi India
                [2 ] Medical Research Council International Statistics and Epidemiology Group Faculty of Epidemiology and Population Health London School of Hygiene and Tropical Medicine London United Kingdom
                [3 ] School of Psychology University of Sussex Brighton United Kingdom
                [4 ] Department of Statistical Science University College London London United Kingdom
                [5 ] Jindal School of Psychology and Counselling O.P. Jindal Global University Sonipat India
                [6 ] Department of Child and Adolescent Psychiatry Institute of Psychiatry, Psychology and Neuroscience King's College London London United Kingdom
                [7 ] Department of Global Health and Social Medicine Harvard Medical School Boston, MA United States
                Author notes
                Corresponding Author: Vikram Patel vikram_patel@ 123456hms.harvard.edu
                Author information
                ©Sonal Mathur, Helen A Weiss, Melissa Neuman, Andy P Field, Baptiste Leurent, Tejaswi Shetty, James E J, Pooja Nair, Rhea Mathews, Kanika Malik, Daniel Michelson, Vikram Patel. Originally published in JMIR Research Protocols (https://www.researchprotocols.org), 13.06.2023.

                This is an open-access article distributed under the terms of the Creative Commons Attribution License ( https://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work, first published in JMIR Research Protocols, is properly cited. The complete bibliographic information, a link to the original publication on https://www.researchprotocols.org, as well as this copyright and license information must be included.

                : 17 August 2022
                : 1 February 2023
                : 21 February 2023
                : 22 February 2023

                adolescent mental health,capacity building,digital training,india,problem-solving intervention,randomized controlled trial


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